Combined Cataract Surgery and Planned Descemetorhexis | NCT02206594

Studies
Combined Cataract Surgery and Planned Descemetorhexis

NCT02206594

Sponsor

Medical College of Wisconsin

Status

Completed

Last Update Posted

Aug 21, 2015Estimated

Enrollment

2Actual

Phase

Not Applicable

Conditions

Fuchs' Corneal Dystrophy
Cataract

Interventions

Descemetorhexis

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Aug 2015Actual

Completion Date

Not provided

First Submitted Date

Apr 18, 2014

First Submission Date that Met QC Criteria

Jul 30, 2014

First Posted Date

Aug 1, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 20, 2015

Last Update Posted Date

Aug 21, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Label	Type	Description	Intervention Names
Descemetorhexis	Experimental		Procedure: Descemetorhexis

Name	Type	Description	Arm Group Labels	Other Names
Descemetorhexis	Procedure		Descemetorhexis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Corneal clarity as assessed by slit lamp photography		Assessed up to 1 year following descemetorhexis

Secondary Outcomes

Measure	Description	Time Frame
Resolution of edema as assessed by slit lamp photography		Assessed up to 1 year following descemetorhexis

Other Outcomes

Measure	Description	Time Frame
Reconstitution of the endothelial cell layer as assessed by specular microscopy		Assessed up to 1 year following descemetorhexis

Eligibility Module

Eligibility Criteria

General Inclusion Criteria:

Patient >18 years old
Willing and able to provide informed consent

Ocular Inclusion Criteria (all ocular inclusion criteria apply only to the study eye):

Fuchs' corneal dystrophy diagnosed
Cataract present
Best corrected visual acuity ≤ 20/40
Candidate for current endothelial transplant procedure (DSAEK, DMEK)

General Exclusion Criteria:

<18 years old
Medically unstable patient
Monocular patient
Unwilling or unable to provide informed consent

Ocular Exclusion Criteria (all ocular exclusion criteria apply only to the study eye):

Corneal dystrophy other than Fuchs'
Central corneal scar or central opacity not related to Fuchs'
Severe nonproliferative diabetic retinopathy or proliferative diabetic retinopathy
History of prior vitreoretinal surgery
Advanced or unstable glaucoma
Known steroid responders with glaucoma

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
The Medical College of Wisconsin		Milwaukee	Wisconsin	53226	United States

Condition Browse Module

MeSH Terms

ID	Term
D005642	Fuchs' Endothelial Dystrophy
D002386	Cataract

Ancestor Terms

ID	Term
D003317	Corneal Dystrophies, Hereditary
D003316	Corneal Diseases
D005128	Eye Diseases
D015785	Eye Diseases, Hereditary

Browse Leaves

Not provided

Browse Branches

Not provided